In consultation with Health Canada, Pendopharm, a division of Pharmascience Inc., is voluntarily recalling two lots of the ACET-650 acetaminophen suppository (DIN 02230437) due to dosage mislabelling on the blister packs inside the box. In the affected lots, some of the suppositories containing 650 mg may be labelled as 325 mg on the blister packs. The external box indicates the correct dose, 650 mg. Due to the error in the labelling, there is a possibility of overdosing, which could potentially lead to liver failure or death. If 650 mg of acetaminophen is taken instead of 325 mg every 4-6 hours, this would exceed the maximum daily dose for children and adults. ACET-650 is an over-the-counter (non-prescription) acetaminophen suppository indicated for relief of mild to moderate pain, and to reduce fever.
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